To assess the safety and tolerability of a single oral dose of the Capecitabine test and reference formulations
- Conditions
- Health Condition 1: null- locally advanced or Metastatic Breast Cancer or Colorectal Cancer adult subjects.
- Registration Number
- CTRI/2012/08/002940
- Lead Sponsor
- Hetero Labs Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 64
1.Established cases of advanced breast cancer or metastatic breast cancer or colo-rectal cancer who are already receiving a stable twice-daily dosing regimen in multiples of 500 mg tablet.
2.Life expectancy of at least 3 months
3.Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
1. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drug, or which may jeopardize the subject in case of participation in the study.
2. Positive alcohol or drug abuse test at baseline.
3. Diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively.
4. Have received any live or live attenuated vaccines within 2 months prior to randomization.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method